JP7007358B2 - Portable injection device - Google Patents

Description

The present disclosure relates to the field of portable injection devices including electroacoustic transducers and methods of operating electroacoustic transducers of portable injection devices. Portable infusion devices are often used in many therapies, especially in the treatment of diabetes by continuous subcutaneous injection of insulin (CSII).

Portable infusion devices have long been known for therapies of diabetes and further therapies with substantially continuous infusions, such as certain pain or cancer treatments. Today's portable injection devices are designed, for example, to be typically sized to fit in the pocket of a trouser and / or to adhere directly and typically to the user's body. It is a small computerized device. The device is carried substantially day and night continuously and is typically designed to administer the drug approximately continuously according to a time-varying basic schedule and the desired amount of drug bols on demand. To.

Insulin preparations infused in CSII, and other typical agents that can be infused, are extremely critical and require precise dosing, resulting in safety and hazard conditions (eg, fluid obstructions, empty drug reservoirs, etc.). Or leakage) and detection of equipment defects are of high importance. Therefore, a state-of-the-art portable injection device typically includes a large number of sensors, as well as safety circuits and software / firmware procedures for monitoring normal operation and performing test or inspection procedures. In addition, portable injection devices typically provide acoustic indicators, such as buzzers, to provide general user feedback, especially to provide alarms or warnings in situations that require the user's attention. , And often include tactile indicators such as pager vibrators.

However, due to the importance and increasing importance of small size and weight for comfort and freedom of movement, the space available for sensors and safety circuits is very limited. In general, the cost of a typical treatment is high, so the cost of the device should also be considered and the number of components should be reduced accordingly.

WO 2004/110528 discloses the use of microphones to detect various defects and / or dangerous situations in the device, including manual or child noise analysis.

European Patent Application Publication No. 05197665 discloses the use of a piezo sensor to obtain an acoustic signal generated by an implantable injection pump and evaluate the signal for failure detection.

U.S. Pat. No. 4,985,015 discloses an embedded infusion device with a piston pump in which the characteristic noise generated by the piston pump during operation is used for monitoring and control of the infusion device. There is.

European Patent Application Publication No. 0519756 discloses the use of a stethoscope to determine the operation of an implantable injection device.

Against this background, it is the overall object of the present disclosure to improve the state of the art with respect to the use of portable injection devices, in particular efficient components. Specific additional advantages of a particular embodiment are described below with the progress of the present specification. An electroacoustic transducer, typically present as an acoustic indicator in a portable injection device, advantageously obtains the acoustic signal generated by the portable injection device during normal operation and / or under certain circumstances. In addition, the goal is achieved based on the insight that it may be used additionally.

In the general method, the overall purpose is achieved by the subject matter of the independent claims. Additional specific advantages are achieved by the dependent claims and the various embodiments defined by the present disclosure as a whole.

In one embodiment, the overall purpose is achieved by a portable injection device including a control unit and an electroacoustic transducer. The control unit is configured to operate the electroacoustic transducer as a noise emitter. The control unit is further configured to operate the electroacoustic transducer as a noise receiver and determine the state of the portable injection device from the received noise received by the electroacoustic transducer. The operation of the transducer as a noise emitter and noise receiver is typically alternative, and the transducer operates as either a noise emitter or an alternative noise receiver. However, it is also possible to simultaneously operate the transducer and / or additional transducers described below as noise emitters and noise receivers.

The determination may include qualitative aspects such as the outline of the frequency spectrum, as well as quantitative aspects such as the amplitude and / or intensity of the received signal, the amplitude of the particular spectral component.

In such devices, electroacoustic transducers serve a dual purpose. When operated as a noise emitter, the electroacoustic converter acts as an acoustic indicator (loudspeaker, buzzer) to provide acoustic instructions and, in particular, acoustic alarms to the user of the device. When operated as a noise receiver, the transducer acts as a microphone to acquire the received noise and the received noise is subsequently evaluated. Various specific examples of noise and evaluation procedures are further described below. As further described below, operating the transducer as a noise receiver is particularly preferred in situations where the normal operation of the portable injection device or its components is to be tested or verified.

The portable injecting device is an in vitro device and may be, in particular, a device used in the treatment of diabetes with CSII, which has already been described and is generally known in the art.

As used herein, the expression "noise" refers to an acoustic signal having sound waves, typically at least partially audible spectrum sound waves. Generally, acoustic signals, noise and sound are understood as synonyms. The noise may be intentionally generated noise or acoustic signals, such as alarm signals generated to provide user feedback, alarms, and the like. However, it may be operating noise such as drive noise that is unavoidable due to the operation of the portable injection device or its components.

The acoustic signals generated to provide user feedback or alarms are advantageous, for example, sounds of constant and known frequencies, acoustic patterns of alternating frequencies, acoustic patterns of increasing and / or decreasing amplitude, and the like. It has a well-defined acoustic pattern.

In one embodiment, the portable injection device may include an additional electroacoustic transducer, which is separate from the electroacoustic transducer. Here, the control unit may be configured to operate an additional electroacoustic transducer as an additional noise emitter. Such additional electroacoustic transducers are particularly advantageous for redundancy purposes and / or for raising the sound level to provide acoustic alarms as described further below.

In an embodiment comprising an additional electroacoustic converter, the control unit operates the electroacoustic converter as a noise emitter to emit additional emission noise while simultaneously operating the electroacoustic converter as a noise receiver. It is configured to let you. Determining the state of a portable injection device from received noise includes, in this type of embodiment, determining whether the received noise matches the additional emitted noise.

In such an embodiment, the normal operation of an additional transducer operating as a buzzer or loudspeaker is tested using the transducer with a microphone. If no noise is received, or if the received noise does not match the expected additional emission noise, a warning or alarm is advantageously provided.

Examining the normal operation of a buzzer or loudspeaker by acquiring and evaluating an emitted noise signal is not clear from all aspects, especially pure electrical testing or inspection, for example, to emitting noise. It has an advantage over pure electrical testing because it takes into account potential problems or imperfections, such as adverse dust or broken fixtures in the transducer. In contrast, in a typical state-of-the-art device, the electroacoustic transducer (buzzer or loudspeaker) is only electrically inspected using techniques such as electrical impedance measurement.

In addition, the error between the emitted noise and the received noise may indicate additional defects in the device, such as housing breakage that can cause the transducer to detune.

Determining whether the received noise matches the emitted noise preferably involves assessing the frequency and / or the amplitude of the received noise. The received noise predicted in normal operation is determined by the amplitude and / or frequency pattern of the acoustic pattern, particularly the acoustic pattern of the emitted noise.

In embodiments with a converter and additional transducers, the converter and the additional converters advantageously receive and / or emit the noise emitted by the additional transducers. The noise to be generated is arranged in an acoustic coupling by structural transmission and / or air transmission acoustic coupling so that it is received by an additional transducer. In general, good acoustic coupling is advantageous. To this end, the transducers and additional transducers may be placed next to each other, for example, close to each other.

In many cases, the transducer present in a portable device, such as a portable injection device as a buzzer / loudspeaker, is realized as a disc-shaped piezoelectric transducer. In a particularly advantageous embodiment comprising a disc-shaped transducer and an additional disc-shaped transducer, the converter and additional transducers are arranged as a stack and advantageously aligned with each other. Typically, both disc-shaped transducers have the same design. The resulting stack has a single transducer footprint and twice the height of a single transducer. Preferably, the transducer and additional transducers are mechanically and acoustically coupled by an adhesive junction.

In embodiments with additional electroacoustic transducers, the control unit controls the additional electroacoustic transducers to operate as additional noise receivers and additional received noise received by the additional electroacoustic transducers. Therefore, it may be configured to determine the additional state of the portable transducer. Advantageously, in such an embodiment, the control unit is further configured to operate the electroacoustic transducer as a noise emitter to emit a noise signal, while operating the additional electroacoustic transducer as a noise receiver. Will be done. Here, determining the additional state of the portable injection device may include determining whether the additional received noise matches the emitted noise by the electroacoustic transducer.

In such an embodiment, the normal operation of the electroacoustic transducer as a buzzer or loudspeaker is acoustically inspected using an additional electroacoustic transducer as a microphone in a manner similar to that described above. May be done.

In embodiments with additional electroacoustic transducers, the control unit may be configured to simultaneously operate both the electroacoustic transducer and the additional electroacoustic transducer as acoustic noise emitters. Here, the control unit may be further configured to operate both the electroacoustic transducer and the additional electroacoustic transducer in common, particularly synchronously. This type of embodiment allows the provision of acoustic instructions, especially alarms, at higher acoustic levels compared to a single buzzer or loudspeaker. Typically for portable injection devices, a buzzer or loudspeaker as a noise emitting element needs to be placed inside the case, resulting in a non-ideal noise emitting situation for the alarm. This is particularly advantageous as acoustic levels are generally a critical issue, especially for waterproof or watertight devices.

In one embodiment, the control unit is configured to control drug administration, whereby the portable injection device emits operating noise. Here, determining the operating state of the portable injection device may include evaluating operating noise. Operating noise is noise emitted by a drive device (motor, gear, bearing, threaded spindle, etc.) and is unique to portable injection devices, depending on their design. Evaluating operational noise is a technique and algorithm commonly known in the art for evaluating acoustic signals, such as filtering (eg, high, low and bandpass filtering), averaging fast Fourier transform (FFT). , Peak detection, pattern recognition, etc. may be included. Signal status and evaluation may be performed by hardware and / or software and firmware running on the control unit's microcomputer or microcontroller in any desired combination.

In embodiments that include evaluating operating noise, the evaluation may include determining whether the driving noise matches the expected operating noise. Advantageously, the portable injection device is configured to generate a warning and / or an alarm if the received noise matches and does not match the expected operating noise.

In embodiments that include assessing operating noise, assessing may include determining whether the operating noise indicates the presence of defects.

In embodiments that include assessing operating noise, the portable injection device may include an electric drive, and the operating noise may include drive noise emitted by the electric drive.

Evaluating the operating noise is to evaluate the operating time of the drive device reflected by the driving noise during drug administration and compare the determined operating time with the predicted operating time according to the dose of the administered drug. May include. In this way, inadequate operation that may occur due to defects may be erroneously determined. In addition, defects associated with drives that operate unintentionally and sustainably may be detected. Such defects are particularly significant as they can cause uncontrolled administration of the drug in large quantities, perhaps the entire contents of the reservoir.

Evaluation of operating noise may include detecting unexpected interruptions in operating noise, especially driving noise, during the operation of the drive. In this way, loose contact can be advantageously detected.

The evaluation of the operating noise may further include determining the rotation direction of the driving device from the operating noise, particularly the driving noise. The direction of rotation can be determined based on the difference in emission drive noise.

The evaluation of operating noise may include detection of the occurrence of step loss if the drive includes a stepper motor or a brushless DC motor. The step loss may be caused by a mechanical overload or may indicate a defect in the device.

Evaluation of operating noise, in particular driving noise, may include assessing the relationship between operating noise and additional sensor signals, the additional sensor signals being generated by the driving sensor and conforming to the predicted relationship. Determine if. The drive sensor may be, in particular, an encoder such as an optical and / or magnetic rotary encoder coupled to the drive shaft and used for drive management and / or control. If the portable injection device operates normally, operating noise and additional sensor signals are compatible.

In embodiments that include assessing operating noise, assessing may include determining whether the operating noise indicates the presence of fluid obstructions in the infusion path.

In embodiments that include evaluating operating noise, the operating noise includes valve switching noise.

In one embodiment, determining the operating state of a portable injection device comprises detecting the occurrence of a mechanical impact.

In one embodiment, the method comprises recording received noise and / or additional received noise in a storage device and / or an external device of a portable injection device. The recorded signal may be used for fault analysis purposes. In addition, the control unit may be configured to compare received noise and / or additional received noise to previously received noise stored in storage. In this way, long-term changes in operating noise, especially drive noise, as an indication of excessive wear may be detected.

In one embodiment, the portable injection device is a drive designed to generate at least one characteristic noise signal for a particular purpose during operation, eg, click noise associated with the normal operation of the drive. Includes equipment. Evaluating received noise and / or additional received noise signals may include determining the presence or absence of characteristic noise signals for a particular purpose. Advantageously, an alarm is provided if characteristic noise for a particular purpose is not detected.

In one embodiment, the portable injection device includes a tactile indicator, such as a pager-type vibrator. The control unit may be configured to operate the tactile display and simultaneously operate the electroacoustic transducer as a noise receiver, and determining the state of the portable injection device from the received noise is the received noise. Includes determining whether the operation of the tactile transducer matches the noise expected to be received. For this type of embodiment, the normal operation of the tactile indicator may be tested in the same way as the electroacoustic transducer and / or additional electroacoustic transducer. This type of embodiment relies on a typical tactile display, in particular a pager-type vibrator, also producing noise that may be received by an electroacoustic transducer acting as a microphone.

In a further aspect, a portable injection system is disclosed. Portable injection systems include portable injection devices and remote devices. The portable injection device includes a control unit and an electroacoustic noise emitter such as a buzzer or loudspeaker that can operate under the control of the control unit. The remote device is advantageously a portable device such as a glucose meter, a diabetes management device which may optionally include a remote control device, or a general purpose device such as a smartphone. Remote devices include noise receivers, such as microphones. Portable injection devices and remote devices are configured to be operably coupled via wireless communication links, such as RF communication links that typically operate under or according to Bluetooth standards. .. The control unit of the portable injection device is configured to activate a noise emitter to emit noise and further transmit the corresponding noise emission notification to the remote device via a communication link. The remote device is configured to activate the electroacoustic receiver when receiving a noise emission notification, and whether the received noise received by the noise receiver matches the emission noise expected to be emitted by the noise emitter. Is further configured to determine. Advantageously, the remote device is further configured to provide an alarm if the received noise does not match the expected emission noise.

The noise emitter of the portable injection device may be a dedicated noise emitter (buzzer, loudspeaker), or may be an electroacoustic transducer that can also operate as a noise receiver. Similarly, the noise receiver of the remote device may be a dedicated noise receiver (microphone) or an electroacoustic transducer that can also operate as a noise emitter.

For this type of portable injection system, the noise emitter of the portable injection device is substantially the same as that previously described in the context of the exemplary embodiment and / or further described below, and in the same manner. Can be applied and inspected acoustically. However, the emitted noise is received by the noise receiver of the remote device.

In a further aspect, the overall purpose is achieved by a method of operating an electroacoustic transducer that is part of a portable injection device. The method comprises operating the electroacoustic transducer as a noise emitter to emit emission noise. The method further comprises operating the electroacoustic transducer as a noise receiver and determining the functional state of the portable injection device from the received noise received by the electroacoustic transducer. The operation as a noise emitter and noise transducer is typically alternative, and the transducer may be operated as a noise emitter or noise receiver at some point. However, in some embodiments, the transducer may be operated simultaneously as a noise emitter and a noise receiver.

In one embodiment, the method may include operating an additional electroacoustic transducer, which is separate from the electroacoustic transducer, as a noise emitter and simultaneously operating the electroacoustic transducer as a noise receiver. Here, determining the state of the portable injection device from the received noise may include determining whether the received noise matches the additional emitted noise emitted by the additional electroacoustic transducer. ..

In one embodiment, the method may include operating both the electroacoustic transducer and the additional electroacoustic transducer simultaneously as acoustic noise emitters. Here, the method may further comprise operating both the electroacoustic transducer and the additional electroacoustic transducer in common, particularly synchronously.

Further embodiments and specific embodiments of the portable injection device and method are further described below in the context of exemplary embodiments.

In a further aspect, the overall purpose is achieved by a method for controlling operation and / or monitoring a portable injection device. The method may include a method for operating the electroacoustic transducer as described above and / or as further described below. The method may further comprise providing a warning if the determined operating condition indicates a defect and / or a malfunction and / or a dangerous condition.

The embodiments of the portable injection device according to the present disclosure may be specifically designed to carry out the corresponding embodiments of the methods according to the present disclosure. Similarly, the methods according to the present disclosure may be performed in particular with and / or by the portable injecting apparatus according to the present disclosure. Therefore, the disclosure of a particular embodiment of the method also discloses the corresponding embodiment of the portable injection device. Similarly, disclosure of a particular embodiment of a portable injection device also discloses embodiments of a corresponding method.

An exemplary embodiment of a portable injection device is shown. A further exemplary embodiment of a portable injection device is shown. The operation flow of the transducer test procedure is illustrated. The operation flow of the alarm procedure is illustrated.

In the following, first, FIG. 1 will be referred to. FIG. 1 schematically illustrates an exemplary embodiment of the portable injection device 1 according to the present disclosure.

The portable injection device 1 includes a control unit 11 realized by an electronic circuit, typically including one or more microcomputers or microcontrollers and auxiliary circuits known in the art. The portable injection device 1 typically further includes an electrically driven device based on the motor 14, such as a DC motor, stepper motor or brushless DC motor commonly known in the art. The motor 14 is operably connected to the spindle drive unit 15. The motor 14 and the spindle drive unit 15 are combined to form a drive chain of the portable injection device 1. In the operating configuration, the spindle drive unit 15 is operably coupled to the piston of the liquid drug cartridge 21. By displacing the piston of the cartridge 21 in a controlled manner, the drug is ejected from the cartridge 21 via the infusion tube 22 and the infusion cannula 23 under the control of the control unit 11. The portable injection device 1 further includes an electroacoustic transducer 12 operably coupled to the control unit 11. Further, the portable injection device 1 includes a tactile display realized as a pager type vibrator 13 operably connected to the control unit 11 and controlled by the control unit 11.

In this regard, the portable infusion device 1 is designed to be widely known in the art and provides, for example, the typical functionality of a portable infusion device used in the treatment of diabetes. In particular, the portable infusion device 1 is used, for example, for the administration of a liquid drug of a liquid insulin formulation, and for the additional administration of a drug bol of a desired size on demand, according to a basal schedule that varies substantially day and night with time. Designed for. It should be noted that the portable injection device 1 includes a power supply, an input unit for inputting user commands, a display, one or more communication interfaces, optical as a part of the motor 14, or operably connected to the motor 14. And / or may include additional components such as rotary encoders and force sensors that measure the force applied to the piston by the drive chain. Corresponding components and devices are commonly known in the art.

The portable injection device 1 further includes a housing 10 that, in operating conditions, includes its components, typically including a cartridge 21.

The control unit 11 controls the entire operation of the portable injection device 1 including the motor 14 for drug administration described above. The control unit 11 further controls the operation of the transducer 12 and related components as described below.

To control the operation of the converter 12, the control unit 11 includes a switch module 111, a noise generation module 112 and an evaluation module 113. It should be noted that the separation of the functional modules shown in FIG. 1 and the drawings below is intended to aid the reader's understanding and is generally exemplary. In one embodiment of the portable injection device 1, especially the control unit 11, a large number of functional modules may be implemented entirely or partially integrally with each other, and any desired combination of hardware. And / or may be implemented by software / firmware.

Although the transducer 12 is exemplified as a piezoelectric transducer, it may be realized as an electromechanical transducer, for example, or may have a different design. The converter 12 can operate as both a noise emitter (speaker, buzzer) and a noise receiver (microphone).

When operating as a noise emitter, the switch module 111 operably connects the converter 12 to the noise generation module 112 as an electric driver circuit. When operating as a noise emitter, the transducer 12 provides acoustic user feedback and / or a defect in the portable injection device 1, clogging (blockage) of the injection tube 22 and / or injection cannula 23, cartridge 21. Demands special attention and / or action from the user, such as emptying. An additional and / or alternative, which acts as an acoustic indicator to warn of a situation, is a pager-type vibrator 13 used in the same manner as the acoustic transducer 12. Advantageously, either or both of the electroacoustic converter 12 and / or the pager type vibrator 13 may be used to provide non-critical display and / or user feedback, while the electroacoustic converter. Both the 12 and the pager type vibrator 13 are activated by the control unit 11 in a critical situation that requires the immediate attention of the user.

When operating as a noise receiver, the switch module 111 operably connects the electroacoustic converter 12 with the evaluation module 113, and the signal received through the electroacoustic converter is processed and / or conditioned on demand. , For example, filtering, amplification, and / or analog to digital conversion may and be evaluated.

When operating as a noise receiver, the electroacoustic transducer 12 functions to receive the operating noise of the portable injection device 1 as received noise, the received noise is converted and further processed by the evaluation module 113. Be evaluated. The electroacoustic converter is acoustically coupled to the drive chain (particularly the motor 14 and spindle drive unit 15) and acoustically by acoustic coupling that is structurally and / or pneumatically transmitted to the pager-type vibrator 13. Is connected.

The control unit 11 operates the electroacoustic transducer 12 as a noise receiver during drug administration, that is, at the same time as the motor 14 for administration of the basic drug or drug bolus is activated. During operation, the motor 14 generally emits drive noise specific to the design of the motor 14 and its operating conditions (particularly rotational speed, load). Similarly, the spindle drive unit 15 emits noise during operation, depending on its design and operating conditions. The noise emitted by the spindle drive unit 15 and the motor 14 in combination is the operating noise during drug administration. The evaluation module 113 is configured to evaluate the operating noise received by the electroacoustic transducer 12 during the operation of the motor 14 and determine whether the operating noise matches the predicted operating noise.

For this purpose, the evaluation module 113 may evaluate the received noise in the time domain and / or the frequency domain (eg, based on the Fast Fourier Transform, FFT) and / or the overall signal amplitude, effective value (squared). Features such as mean, RMS) may be evaluated. The evaluation of received noise is typically performed as software and firmware code, respectively, but may include additional or alternative hardware components.

Defects are detected by the evaluation module 113 because defects in typical equipment, especially those in the drive chain, result in deviations from the expected operating noise. For example, excessive wear, dust or dirt (above normal and acceptable levels) typically causes an increase in the overall noise level. Broken or defective teeth of the reduction gear, which typically forms part of the motor 14 and / or the spindle drive unit 15, causes a characteristic signal with a frequency dependent on the rotational speed. Further defects that can be detected are outlined above.

During drug administration, in addition to determining whether the operating noise matches the predicted operating noise, the control unit 11 activates the motor 14 and the operating noise is predicted as part of the drive test procedure. It may be determined whether or not it matches. Such a drive test procedure may advantageously be performed automatically, for example at the time of replacement of the drug cartridge 21. The spindle drive unit 15 is part of the portable injection device 1 integrated and accordingly from the forward position (corresponding to the empty drug cartridge 21) to the retracted position (corresponding to the full drug cartridge 21). If it needs to be moved, the drive test procedure may be performed while the motor 14 is operating for backward movement.

The determination of whether the received noise matches the expected operating noise during drug administration is advantageously due to the presence (blockage) of the operational noise in the flow path, particularly the infusion tube 22 and / or the infusion cannula 23. It may be further used to determine if it indicates. In the case of obstruction, an attempt to administer more drug from the cartridge 21 (more specifically, activation of the motor 14) causes the internal fluid pressure to rise sharply, and accordingly, a force acting against the drive chain. However, it rises sharply until the motor 14 finally stalls. This process typically involves a change in properties in motor noise over time, typically with a temporary increase in overall operating noise, especially before the motor 14 finally stalls.

As already mentioned, the electroacoustic converter 12 is advantageously further acoustically coupled to the pager-type vibrator 13, and the evaluation unit 113 simultaneously operates the pager-type vibrator 13 while operating the electroacoustic converter 13. It may be configured to determine whether the received noise received by 12 matches the expected noise. The predicted noise depends on the design and control of the pager type vibrator 13 and, in the case of a typical design with an eccentric mass connected to a small motor and its drive shaft, a rotational speed. The activation of the pager-type vibrator 13 and the determination of whether the electroacoustic transducer 12 receives the corresponding signal may be performed under the control of the control unit 11 as part of a dedicated pager test procedure. Such pager test procedures may be initiated, for example, at power-up of the portable injection device 1, replacement of the drug cartridge 21, and / or at predetermined time intervals, eg, once a day. The pager test procedure may be performed when the pager-type vibrator 13 is activated to provide instructions to the user of the device.

Numerous additional methods, procedures and algorithms for evaluating signals received by electroacoustic transducers or microphones to determine the operational status of portable injectors are referenced in this regard. It is disclosed in 110528.

In the following, FIG. 2 further illustrates a further embodiment of the portable injection device 1 according to the present disclosure. Since the embodiment of FIG. 2 is consistent with the embodiment of FIG. 1 in many respects, only the differences will be described below.

In the embodiment of FIG. 2, in addition to the electroacoustic converter 12, an additional electroacoustic converter 12a is present, and in addition to the noise generation module 112, an additional noise generation module 112a is provided. The noise generation module 112 is associated with the converter 12, and the additional noise generation module 112a is associated with the additional converter 12a. The transducer 12 and the additional transducer 12a may have the same design, eg, a piezoelectric buzzer, but they are separate and can operate independently of each other. Both the converter 12 and the additional converter 12a may be operated as a sounding device or a sound receiving device. The switch module 111 can operate the converter 12 at the same time as the noise generating module 112 and the additional converter 12a including the additional noise generating module 112a in order to operate the converter 12 and the additional converter 12a as voice emitters. It is configured to connect to. The switch module 111 operably connects either the transducer 12 or the additional transducer 12a with its associated sound modules 1112, 112a for operation as a noise emitter, and simultaneously converts. The other of the device 12 and the additional transducer 12a is further configured to be operably coupled to the evaluation module 113 for operation as a noise receiver.

The transducer 12 and the additional transducer 12a are functionally separate from each other and may be operated separately from each other. However, they are acoustically coupled so that the emission noise may be received by the converter 12 as additional reception noise by the additional transducer 12a. Similarly, the additional emission noise by the additional transducer 12a may be received by the transducer 12 as received noise. In a typical exemplary embodiment, the transducer 12 and the additional transducer 12a are disc-shaped piezoelectric converters that are stacked together and coupled by an adhesive junction as described above.

One or both of the transducer 12 and the additional transducers 12a may be operated as noise emitters and acoustic indicators, respectively, to provide acoustic instructions to the user of the device. In one embodiment, the control unit 11 controls the activation of both transducers to be activated in common, whereby the noise generation module 112 and the additional noise generation module 112a have, for example, the same noise signal. Produces an increase in noise level compared to a single converter. Alternatively, the control unit controls only one of the transducers, eg, converter 12 activation, when providing non-critical user feedback and / or general information, but for example, device errors or device errors as described above. It controls the activation of both the converter 12 and the additional transducer 12a to provide warnings that require direct attention, such as blockages. In such situations, especially in the case of hermetically sealed and watertight housing 10, acoustic alarm levels are a serious issue, and sufficient acoustic alarm levels, especially default minimum alarm levels, are typically for regulatory reasons. The use of both transducers is advantageous as it will be satisfied.

To test normal operation, one of the converter 12 and the additional transducer 12a is operated as a noise emitter, while the other of the converter 12 and the additional transducer 12a is as a noise receiver. It is determined whether the signal operated and received by the receive transducer matches the expected noise transmitted by the transmit transducer. The corresponding test procedure may be performed as a dedicated transducer test procedure in the same manner as the pager test procedure described above. Such transducer test procedures may be initiated, for example, at power-up of the portable injection device 1, replacement of the drug cartridge 21, and / or at predetermined time intervals, eg, once a day. The transducer test procedure may be performed when the transducer 12 and / or the additional transducer 12a is activated to provide instructions or warnings to the user of the device.

In the following, further refer to FIG. 3, which schematically illustrates the operating flow of an embodiment of a transducer test procedure that may be performed using the portable injection device 1 shown in FIG.

The test procedure is started in step (S). In a subsequent step (S1), the switch module 111 operably connects the converter 12 with the noise generator 112 for operation as a noise emitter, and the additional transducer 12a of operation as a noise receiver. Therefore, it is operably connected to the evaluation module 113. Further, in step (S1), the converter 12 is operated as a noise emitter to emit a noise signal generated by the noise generation module 112, while an additional converter 12a is operated as a noise receiver to receive. The noise is evaluated by the evaluation unit 113. In the subsequent step (S2), it is determined whether the noise received by the additional transducer 12a matches the noise signals generated by the noise generator 112 and emitted by the converter 12, respectively, and the result is The operation flow branches accordingly. If affirmative, the test is successful and ends at step (E). In the opposite case, step (S3) is performed and the corresponding warning or alarm is generated and displayed on the display of the portable infusion device and / or to an additional device such as a portable device, smartphone, etc. It is transmitted and the converter tester ends (E). Further, in step S3, an additional acoustic transducer 12a (ie, a transducer that has not been activated to act as a noise emitter in step S2) is operably coupled to the noise generation module 112 in an alternative or additional manner. , Then may be controlled to emit an acoustic warning or error signal. In this way, the acoustic alarm may be given even if the transducer 12 is defective. Note that the procedure of FIG. 3 may be performed in a similar manner, with the roles of the transducer 12 and the additional transducer 12a reversed.

In the following, further refer to FIG. 4, which illustrates an exemplary operating flow of an alarm procedure that provides an acoustic alarm to the user of the portable injection device 1 of FIG. The operating flow includes test procedures for the transducer 12 and additional transducers 12a.

The alarm procedure is started in step (S). In a subsequent step (S100), the switch module 111 operably connects the converter 12 with the noise generator 112 for operation as a noise emitter, and the additional transducer 12a operates as a noise receiver. Therefore, it is operably connected to the evaluation module 113. Further, in step (S100), the converter 12 is activated as a noise emitter, thereby issuing an acoustic alarm signal, while the additional transducer 12a is operated as a noise receiver, and the received noise is evaluated. Evaluated by unit 113. In a subsequent step (S101), it is determined whether the noise received by the additional transducer 12a matches the alarm signals generated by the noise generator 112 and emitted by the transducer 12, respectively, depending on the result. The operation flow branches.

If the result is affirmative in step S101, generally, steps S110, S111 corresponding to steps S100, S101 already described are subsequently executed. However, the roles of the transducer 12 and the additional transducer 12a are opposite. That is, the additional transducer 12a is operably coupled with the additional noise generation module 112a for operation as a noise emitter, and the transducer 12 operates with the evaluation module 113 for operation as a noise receiver. Can be connected.

If the result is affirmative in step S111, both the transducer 12 and the additional transducers are operating correctly. In a subsequent step (S112), the switch module 111 operably connects the converter 12 with the noise generating module 112, and at the same time operably connects the additional converter 12a with the additional noise generating module 112a. Both the 12 and the additional transducer 12a operate as noise emitters to provide acoustic alarms.

Each of the signal received by the additional transducer 12a (step (S100)) and the signal received by the converter 12 (step (S110)) is generated by the noise generating module 112 and the additional noise generating module 112a, respectively. If the signal does not match, the operation flow branches into step (S120) at step (S101) and step (S113) at step (S111). In step (S120), the alarm signal is emitted by the additional transducer 12a, and in step (S113), the alarm signal is emitted by the transducer 12. In both steps (S120) and (S113), the corresponding warning or alarm is generated and displayed on the display of the portable injection device and / or transferred to the additional device as described above and the transducer. It provides a warning that each of the 12 and the additional converter 12a is defective.

The portable injection device shown in FIGS. 1 and 2 and the operation flow shown in FIGS. 3 and 4 may be changed and changed in many respects.

In the embodiment of FIG. 2, the separate noise generation modules S112, 112a were expected to be associated separately with the transducer 12 and the additional transducer 12a. This is advantageous as long as the redundancy provided by the two transducers S12, 12a extends to the noise generation modules S112, 112a. For example, if the noise generation module 112 (including the power supply or driver circuit) is defective, the acoustic alarm may still be provided by the additional noise generation module 112a and the additional converter 12a. However, as an alternative, the additional noise generating module 112a may be excluded and the noise generating module 112 may be operably coupled to the transducer 12 and / or the additional transducer 12a.

It is generally advantageous to provide non-visual (acoustic and / or tactile) display, and in particular at least two different means for alerting the user. For this reason, in the embodiment of FIG. 1 with a single transducer 12, a pager-type vibrator 13 is provided. In the embodiment of FIG. 2, the pager type vibrator is not required because of the additional converter 12a and the additional noise signal generator 112a. However, the pager vibrator 13 may optionally be present and may serve as an additional alarm device, eg, to provide individualized instructions and / or user feedback, especially in non-critical situations.

In FIGS. 1 and 2, both the motor 14 and the spindle drive unit 15 are integrated parts of the portable injection device. In an alternative configuration, the threaded rod or spindle is an integral part of the cartridge 14, while the corresponding drive nut is part of the portable injection device 1 and vice versa.

In a further configuration, the portable infusion device 1 is not designed as a typical syringe pump device in which the drug is weighed and dispensed directly from the cartridge 21. Alternatively, a downstream dosing structure may be anticipated in which the main reservoir (eg, cartridge 21 or bag, pouch, etc.) is fluid-coupled to the intermediate dosing cylinder, from which the drug is weighed and administered. In this case, the motor 14 is operably coupled to the dosing unit to form a small syringe pump in the operating state. A valve unit is provided, typically implemented integrally with the dosing cylinder for an alternative fluid coupling between the dosing cylinder and the main reservoir or infusion tube 22. The valve unit may also be switched or actuated by the motor 14, or the portable injection device may have a dedicated valve switching drive that is operably coupled to the valve unit. Suitable dosing unit designs and structures are disclosed, for example, in European Patent Application Publication No. 2163273, European Patent Application Publication No. 2881128. If a separate drive unit anticipates switching valves, its operating noise may be tested in the same manner as previously described in the context of FIG. In addition, the converter 12 and / or additional converter 12a may receive valve switching noise associated with valve switching, where the valve switching noise matches the expected valve switching noise. It may be evaluated by the evaluation unit 113 to determine whether or not.

Independent of the particular design and structure, the portable infusion device 1 is generally designed to administer a well-defined drug volume in a controlled manner that is substantially independent of pressure conditions. It is realized as a volumetric measuring pump and a positive displacement pump, respectively.

The portable injection device 1 may be configured to be carried in the pocket of the trousers, that is, without being directly attached to the body, using, for example, a belt clip or the like. Alternatively or additionally, the portable injection device 1 may be designed so that the injection cannula 23 protrudes from the housing 10 and is attached directly to the wearer's body, for example with adhesive tape.

During normal operation and when the transducer 12 and / or additional transducer 12a can be operably coupled to the evaluation unit 113, the evaluation unit 113 can occur and cause damage if the portable injection device 1 is dropped. It may be configured to detect the occurrence of mechanical shock. When a mechanical impact is detected, the (self) test procedure may be started automatically and / or a warning or alarm may be generated.

Claims (17)

a) Control unit (11) and
b) Electroacoustic transducer (12) and
c) With an additional electroacoustic transducer (12a)
A portable injection device (1) including the above.
The electroacoustic transducer (12) and the additional electroacoustic transducer (12a) can operate as noise emitters and noise receivers, respectively.
The control unit (11) operates at least the electroacoustic converter (12) and the additional electroacoustic converter (12a).
-The additional electroacoustic transducer (12a) is operated as a noise emitter, and
The first operation, in which the electroacoustic transducer (12) is operated as a noise receiver and the state of the portable injection device (1) is determined from the received noise received by the electroacoustic transducer (12).
and,
-The electroacoustic converter (12) is operated as a noise emitter , and
The additional state of the portable injection device (1) from the additional received noise received by the additional electroacoustic transducer (12a) by operating the additional electroacoustic transducer (12a) as a noise receiver. Second operation to determine
A portable injection device (1) configured to be selectively selectable from the above. The portable injection device according to claim 1, wherein the control unit (11) includes a switch module (111) for switching the operation of the electroacoustic converter (12) and the additional electroacoustic converter (12a). (1). In the first operation, the control unit (11) operates the additional electroacoustic converter (12a) as a noise emitter so as to emit additional emission noise, while operating the electroacoustic converter (12). ) Is configured to operate as a noise receiver at the same time.
The portable type according to claim 1 or 2, wherein determining the state of the portable injection device (1) from the received noise includes determining whether or not the received noise matches the additional emitted noise. Injection device (1). In the second operation, the control unit (11) operates the additional electroacoustic converter (12a) as a noise receiver, and the additional reception received by the additional electroacoustic converter (12a). The noise is configured to determine the additional state of the portable transducer (1).
The control unit (11) operates the additional electroacoustic converter (12a) as a noise receiver, and simultaneously operates the electroacoustic converter (12) as a noise emitter so as to emit emission noise. Further configured, determining the additional state of the portable injection device (1) comprises determining whether the additional received noise matches the emitted noise, according to claims 1-3. The portable injection device (1) according to any one of the items . The control unit adds the operations of the electroacoustic converter (12) and the additional electroacoustic converter (12a) to the first operation and the second operation, and the electroacoustic converter (12). And both the additional electroacoustic transducer (12a) are simultaneously operated as acoustic noise emitters, and both the electroacoustic transducer (12) and the additional electroacoustic converter (12a) are operated in common. The portable injection device (1) according to any one of claims 1 to 4, further selectable from the third operation . The control unit (11) is configured to synchronously operate both the electroacoustic transducer (12) and the additional electroacoustic converter (12a) in the third operation. 5. The portable injection device (1) according to 5. a) Control unit (11) and
b) With the electroacoustic transducer (12)
A portable injection device (1) including the above.
Alternatively, the control unit (11) may be used.
-Whether the electroacoustic converter (12) is operated as a noise emitter or
or,
The electroacoustic transducer (12) is operated as a noise receiver, and the state of the portable injection device (1) is determined from the received noise received by the electroacoustic transducer (12).
Is configured as
The control unit (11) is configured to control drug administration, whereby the portable injection device (1) emits operating noise, and it is possible to determine the operating state of the portable injection device (1). , Including evaluating the operating noise
The operating noise includes a valve switching noise, and is a portable injection device (1). The portable injection device (1) according to claim 7, wherein evaluating the operating noise includes determining whether or not the operating noise matches the predicted operating noise. The portable injection device (1) according to claim 7 or 8, wherein evaluating the operation noise includes determining whether or not the operation noise indicates the presence or absence of a fluid obstruction in the injection path. The portable injection device (1) according to any one of claims 7 to 9, wherein evaluating the operating noise includes determining whether or not the operating noise indicates the presence of a defect. The portable injection device (1) includes an electric drive device (14), and the operating noise includes a drive noise emitted by the electric drive device (14), according to any one of claims 7 to 10. The portable injection device (1) according to the above. The portable injection device (1) according to any one of claims 1 to 11 , wherein determining the state of the portable injection device (1) includes detecting the occurrence of a mechanical impact. A method of operating an electroacoustic transducer (12) and an additional electroacoustic transducer (12a) that are part of a portable injection device (1).
The electroacoustic transducer (12) and the additional electroacoustic transducer (12a) can operate as noise emitters and noise receivers, respectively.
The method is at least
The additional electroacoustic transducer (12a) is operated as a noise emitter and emits additional emission noise.
The first operation, in which the electroacoustic transducer (12) is operated as a noise receiver and the state of the portable injection device (1) is determined from the received noise received by the electroacoustic transducer (12).
and,
The electroacoustic transducer (12) is operated as a noise emitter so as to emit emission noise, and the electroacoustic converter (12) is operated as a noise emitter .
The additional electroacoustic transducer (12a) is operated as a noise receiver, and the additional state of the portable injection device (1) is determined from the additional received noise received by the additional electroacoustic transducer (12a) . Second action to do
A method comprising selecting the operation of the electroacoustic transducer (12) and the additional electroacoustic transducer (12a) from . In the first operation, determining the state of the portable injection device (1) from the received noise means that the received noise is emitted by the additional electroacoustic converter (12a). 13. The method of claim 13 , comprising determining whether or not the emission noise is consistent with. In the second operation, determining the additional state of the portable injection device (1) from the additional reception noise means that the additional reception noise is emitted by the electroacoustic transducer (12). The method according to claim 13 or 14, comprising determining whether or not the emission noise is matched. The operation of the electroacoustic converter (12) and the additional electroacoustic converter (12a) uses both the electroacoustic converter (12) and the additional electroacoustic converter (12a) as acoustic noise emitters. Further comprising a third operation, which operates simultaneously and commonly operates both the electroacoustic converter (12) and the additional electroacoustic converter (12a).
In the method, the operation of the electroacoustic transducer (12) and the additional electroacoustic transducer (12a) is selected from the third operation in addition to at least the first operation and the second operation. The method according to any one of claims 13 to 15, comprising the above. 16. The method of claim 16, wherein the method comprises synchronously operating both the electroacoustic transducer (12) and the additional electroacoustic transducer (12a) in the third operation .

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